Cleaning Validation Engineer
2210 Lake Shore Dr BullValley, IL 60098
This resource will serve as a primary validation contact to support cleaning development, validation and revalidation activities for solution, suspension and emulsion products.
Location/Travel: Expected to be physically present at the Woodstock facility on fulltime basis during normal business hours (8 am - 5 pm Monday-Friday). Off shift availability is required depending on the needs for the project.
Reporting: This position will primarily report to Validation Supervisor.
• Generate and maintain cleaning validation master plan every year.
• Proper sampling technique for swab and rinse samples (Demonstration through swab sampling certification program at the site is required after hire)
• Sponsor change controls for SOPs and Batch Records to update cleaning process for current products
• Act as Subject Matter Expert for cleaning validation and provide consultation to third party labs for test method development and method validation.
• Actively provide input and guidance in establishing cleaning process for new products and partner with new product development engineers for process development.
• Closely work with Operations, Manufacturing Quality, Chemistry, New Product Development and third-party labs to coordinate cleaning validation execution, sample testing and data reporting.
• Conduct risk assessment of existing and new processes/technology/ equipment and manage the impact of potential failure
• Complete oversight of end to end process for protocol execution and closure
• Other responsibilities as assigned
Must Have Skills:
• The candidate must be well organized and technically sound in understanding of cleaning validation principles including development of acceptance criteria, worst case product determination from matrix of products.
• Strong technical writing including protocol generation, deviation investigation and generation as well as report writing
• Ability to investigate and resolve cleaning validation related Out of Specifications results and deviations
• Proven hands on experience with pharmaceutical and biologic product Process Equipment
Nice to have Skills:
• Understanding of process configuration drawings
• Familiarity with Blow-Fill-Seal Equipment, Process Tanks, Process Piping, Pumps, Filter Housings etc.
• Ability to provide consultation and input to Change Controls and Documentation (SOPs, Training Documents, Batch Records, test methods etc.) as it relates to cleaning process.
• Good understanding of change control process for pharmaceutical operations
• Knowledge of cleaning validation test method development.
• Technical aptitude and ability to work in fast pace environment with competing priorities
• Operate with minimum direction and supervision and be able to manage and track status of each activity
• Identify and help implement solutions to the problems
• Excellent GDP practices and legible handwriting
• On time task/ project completion
• Clear and precise communication
• Proficient with the MS Office Suite
• The job may require to hands-on operation, assembly/disassembly of pieces of manufacturing equipment to collect samples.
• Standing, walking, bending, climbing, reaching and lifting upward of 20-30 pounds may be required.
• Personal Protective Equipment and aseptic gowning such as gloves, a full Tyvek suit, face mask etc. may be required.
• Minimum B.S. degree required, preferably chemical engineering or chemistry.
• Candidates With minimum 5 years of pharmaceutical or biologics industry experience including a minimum of 2 years of cleaning validation experience will be considered.
Work Environment: fast-paced cubical, at times will also enter cleanroom (full gowning) - Most work will be at desk. Term/Length: 6 months with possible extension Job Details: Will be running cleaning validation programming. Variety of cleaning. CIP based or saline or water based. Must have pharmaceutical and solutions based background. Strong understanding of PDA/FDA regulations on cleaning validation. Prepare and execute protocols and reports for cleaning validation. Must have 3-5 years’ experience in cleaning validation. Education Requirements: B.S. degree required, preferably in chemical engineering or chemistry Experience Requirements: Must have 3-5 years Cleaning Validation in Pharmaceutical Computer/Equipment/Instrument Requirements: MS office and exp in technical writing intermediate to advance skills in Excel, Word an PPT Work Schedule: M-F 8-5 - will vary as it may need off hours due to manufacturing. 80-90 reg schedule other after hours or weekends